Remimazolam

(Byfavo®)

Remimazolam

Drug updated on 11/5/2024

Dosage FormInjection (intravenous; 20 mg lyophilized powder for reconstitution)
Drug ClassBenzodiazepines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

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Summary
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  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • In procedural sedation for older patients, remimazolam demonstrated no significant differences in sedation success, dizziness, postoperative nausea and vomiting, or recovery time when compared to other sedatives.
  • During gastroscope sedation, remimazolam significantly reduced the incidence of respiratory depression, hypoxemia, bradycardia, dizziness, injection site pain, and hypotension compared to propofol.
  • When combined with flumazenil, remimazolam shortened emergence time, extubation time, and post-anesthesia care unit (PACU) stay compared to propofol, while also reducing the incidence of respiratory depression.
  • For gastrointestinal endoscopy, remimazolam showed higher procedural success and a lower need for rescue medication, along with a reduced incidence of hypotension and adverse events compared to midazolam.
  • Remimazolam was associated with a lower incidence of hypotension, bradycardia, respiratory depression, and injection pain compared to propofol across various sedation settings.
  • When used with flumazenil, remimazolam reduced the incidence of respiratory depression but increased the risk of re-sedation compared to propofol.
  • Hypotension and bradycardia were the most commonly reported adverse events, with rare cases of cardiac arrest observed.

Product Monograph / Prescribing Information

Document TitleYearSource
Byfavo (remimazolam) Prescribing Information.2023Acacia Pharma, Inc., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Remimazolam-Induced Anaphylaxis and Cardiovascular Collapse: A Narrative Systematic Review of Eleven Cases2024Medicina (Kaunas, Lithuania)
Remimazolam for Procedural Sedation in Older Patients: A Systematic Review and Meta-Analysis with Trial Sequential Analysis2024Journal of Personalized Medicine
The safety of remimazolam versus propofol in gastroscopic sedation: a meta-analysis2024BMC Anesthesiology
Comparison of Remimazolam-Flumazenil versus Propofol for Recovery from General Anesthesia: A Systematic Review and Meta-Analysis2023Journal of Clinical Medicine
Hemodynamic Influences of Remimazolam Versus Propofol During the Induction Period of General Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials2023Pain Physician
Remimazolam versus propofol for procedural sedation: a meta-analysis of randomized controlled trials2023Peer Journal
The comparison of remimazolam and midazolam for the sedation of gastrointestinal endoscopy: a meta-analysis of randomized controlled studies2022African Health Sciences
Efficacy of Remimazolam for Procedural Sedation in American Society of Anesthesiologists (ASA) I to IV Patients Undergoing Colonoscopy: A Systematic Review and Meta-Analysis2022Cureus
Hypotension during propofol sedation for colonoscopy: a retrospective exploratory analysis and meta-analysis2022British Journal of Anaesthesia
Efficacy and Safety of Remimazolam for Procedural Sedation: A Meta-Analysis of Randomized Controlled Trials With Trial Sequential Analysis2021Frontiers in Medicine
Efficacy and Safety of Remimazolam in Endoscopic Sedation-A Systematic Review and Meta-Analysis2021Frontiers in Medicine

Clinical Practice Guidelines